Medicis calls on FDA to amend draft guidance

4/4/2008

SCOTTSDALE, Ariz. Medicis is arguing in a citizen’s petition aimed at the Food and Drug Administration that a waiver provision in its draft guidance of bioequivalence requirements would put the public at risk.

The company is directly referring to its acne drug Solodyn. Medicis doesn’t want the FDA to approve any generic version of the drug without bioequivalence testing for each strength of the drug.

As of now, the draft guidelines only require testing for the highest strength of the drug, 135 mg, and gives a waiver to the 45 and 90 mg strengths as long as they are “proportionally similar” to the 135 mg tablet.

But, according to Medicis’ March 20 petition, the 45 and 90 mg strengths of Solodyn are not dose-proportional to the 135 mg strength. The company had believed the various strengths to be proportional, but newer bioequivalence data has shown otherwise, it says. Therefore, it also is asking the FDA to designate the 90 mg Solodyn as a separate reference-listed drug from the 135-mg strength.

X
This ad will auto-close in 10 seconds